PaO2/FiO2*PEEP (P/FP) Ratio and Mortality in Acute Respiratory Distress Syndrome.

NCT ID: NCT03946150

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4361 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2020-03-03

Brief Summary

The PaO2/FiO2 (P/F) ratio is same for all the Positive End Expiratory Pressure (PEEP) ≥ to 5. This P/F ratio misleads the severity of disease without the knowledge of set PEEP. The Oxygenation status is actually worse when the patient is using high PEEP.

P/F Ratio doesn't include PEEP in the calculation.The P/F ratio doesn't show the severity of the disease appropriate for the set PEEP.

PaO2/(FiO2 X PEEP) P/FP Ratio is a new Formula which addresses this gap to appropriately calculate the severity of the disease by including PEEP in the formula.

This formula is used to predict mortality for different severities of ARDS.

Detailed Description

The Main aim of this study is to analyse whether this formula can early diagnose the severity of the disease appropriate for the set PEEP, so the Rescue measure can be started early which can eventually decreases the mortality.

Increasing the PEEP Value with the same Fio2 gives a different PaO2 and SpO2. The oxygenation improves substantially by increasing only the PEEP. So including the PEEP in calculating the severity of Oxygenation is better than the current practice.

The current Definition of ARDS for Oxygenation is P/F Ratio of 300 to 200 is Mild, 200 to 100 is Moderate and less than 100 is Severe ARDS with PEEP ≥ 5.

The New P/FP Ratio of 300 to 200 is mild, 200 to 100 is moderate and less than 100 is severe Adult Respiratory Distress Syndrome (ARDS) for all the different levels of PEEP values.

Conditions

Adult Respiratory Distress Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

P/FP Ratio

P/FP Ratio is calculated in ARDS Patients retrospectively and analyse whether this new formula with PEEP can appropriately diagnose the Severity of Oxygenation with different levels of PEEP.

P/FP Ratio

Intervention Type: DIAGNOSTIC_TEST

PaO2/Fio2 X PEEP

P/F ratio

P/F ratio is the current Berlin definition of ARDS in Calculating the severity of Oxygenation.

P/FP Ratio

Intervention Type: DIAGNOSTIC_TEST

PaO2/Fio2 X PEEP

Interventions

P/FP Ratio

PaO2/Fio2 X PEEP

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Intubated patients for

• Adult Respiratory Distress Syndrome
• Stroke
• Seizures
• Post neurosurgery
• Endoscopy Procedure
• Post Cardiac Collapse

Exclusion Criteria

Non intubated patients on

• Room Air
• Nasal Cannula
• Face mask
• Venturi Mask
• Non Rebreathing mask

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Health System, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Sunitha PalaniDurai

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sunitha PalaniDurai

Role: PRINCIPAL_INVESTIGATOR

National University Health System, Singapore

Locations

National Universty Health System

Singapore, , Singapore

Countries

Singapore

References

Palanidurai S, Phua J, Chan YH, Mukhopadhyay A. P/FP ratio: incorporation of PEEP into the PaO2/FiO2 ratio for prognostication and classification of acute respiratory distress syndrome. Ann Intensive Care. 2021 Aug 9;11(1):124. doi: 10.1186/s13613-021-00908-3.

Reference Type: DERIVED

PMID: 34370116 (View on PubMed)

Other Identifiers

NUHSSingapore

Identifier Type: -

Identifier Source: org_study_id